Corcept Therapeutics Announces Third Quarter Financial Results and Provides Corporate Update

On November 3, 2022 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrine, oncologic, metabolic and neurological disorders by modulating the effects of the hormone cortisol, reported its results for the quarter ended September 30, 2022 (Press release, Corcept Therapeutics, NOV 3, 2022, View Source [SID1234622970]).

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Financial Results

Revenue of $101.7 million, compared to $96.1 million in third quarter 2021
Tightened 2022 revenue guidance of $400 – $410 million
Diluted net income per common share of $0.30, compared to $0.24 in third quarter 2021
Cash and investments of $401.2 million, compared to $382.0 million at June 30, 2022
Corcept’s third quarter 2022 revenue was $101.7 million, compared to $96.1 million in the third quarter of 2021. Third quarter operating expenses were $69.8 million, compared to $59.9 million in the third quarter of 2021, due to increased clinical trial and sales and marketing activities and expenses to support the expansion of our clinical development and commercial teams. Net income was $34.6 million in the third quarter of 2022, compared to $30.5 million in the third quarter of 2021.

Cash and investments of $401.2 million at September 30, 2022 reflects the acquisition in the third quarter of $15.5 million of Corcept common stock in connection with the exercise of employee stock options and vesting of restricted stock grants.

"Diagnosing and treating patients with a complex disease such as Cushing’s syndrome requires frequent in-person contact with physicians. Our revenue in the third quarter was affected by fewer than expected in-person interactions as many physician practices have not returned to pre-pandemic patterns of activity. To reflect this near-term challenge, we are tightening our 2022 revenue guidance to $400 to $410 million," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "We remain extremely optimistic about the present and the future of our Cushing’s syndrome business. Korlym is an excellent treatment for patients with Cushing’s syndrome and there are many eligible patients who have yet to receive it. We are making substantial investments to improve the screening and treatment of these patients and we are confident that these initiatives will contribute to our results in the coming quarters."

Clinical Development

"Our clinical trials continue to advance and generate data supporting cortisol modulation’s broad therapeutic potential," added Dr. Belanoff. "We are very excited about our most recently initiated studies: ROSELLA, our confirmatory Phase 3 trial in platinum-resistant ovarian cancer; and DAZALS, our Phase 2 trial in ALS. We are also looking forward to important readouts from our two Phase 2 trials in antipsychotic-induced weight gain by the end of this year."

Oncology

Enrollment continues in ROSELLA – 360-patient pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in patients with recurrent, platinum-resistant ovarian cancer
Enrollment continues in open-label, Phase 1b trial of relacorilant plus
pembrolizumab in patients with adrenal cancer with cortisol excess
Randomized, placebo-controlled Phase 2 trial of relacorilant plus enzalutamide in patients with prostate cancer to begin next year in collaboration with the University of Chicago
"We and our investigators are excited that ROSELLA is active and enrolling patients," said Bill Guyer, PharmD, Corcept’s Chief Development Officer. "Our goal in this trial is to replicate the positive results of our successful Phase 2 study, which demonstrated improvements in progression-free survival, duration of response and overall survival, all without increasing side effect burden. Women with platinum-resistant ovarian cancer do not have good treatment options and relacorilant plus nab-paclitaxel has the potential to become a new standard of care."

Amyotrophic Lateral Sclerosis (ALS)

Enrollment continues in DAZALS – 198-patient, randomized, double-blind, placebo-controlled Phase 2 trial of dazucorilant in patients with ALS
"ALS, also known as Lou Gehrig’s disease, is a devastating neuromuscular illness with an urgent need for better treatment," said Dr. Guyer. "Dazucorilant showed great promise in animal models of ALS – improving motor performance and reducing neuroinflammation and muscular atrophy. We are excited to initiate this important study in collaboration with TRICALS, the leading ALS academic consortium in Europe, to investigate dazucorilant’s potential to significantly improve the lives of patients with ALS."

Metabolic Diseases

Enrollment completed in GRATITUDE and GRATITUDE II – two double-blind, placebo-controlled Phase 2 trials of miricorilant to reverse recent and long-standing antipsychotic-induced weight gain (AIWG) – data from both trials expected this quarter
Enrollment continues in Phase 1b dose-finding trial of miricorilant in patients
with presumed non-alcoholic steatohepatitis (NASH) – data expected in the first half of 2023
"We expect our double-blind, placebo-controlled GRATITUDE and GRATITUDE II trials in patients with AIWG to build on the positive data from our Phase 1 studies," said Dr. Guyer. "There is a substantial opportunity to improve the medical care of these patients as weight gain and other adverse metabolic effects caused by antipsychotic medications dissuade many patients from adhering to their treatment regimen, pose serious health risks and reduce the life expectancy of millions of patients."

"The goal of our Phase 1b dose-finding study in patients with NASH is to identify a dosing regimen that captures the unprecedented rapidity and magnitude of liver fat reduction observed in our prior study without causing excessive liver irritation," added Dr. Guyer.

Cushing’s Syndrome

Enrollment continues in Phase 3 GRACE trial of relacorilant as a treatment for patients with all etiologies of Cushing’s syndrome – new drug application (NDA) submission expected
in second half 2023
Enrollment continues in Phase 3 GRADIENT trial of relacorilant as a treatment for patients
with Cushing’s syndrome caused by adrenal adenomas
"We advanced relacorilant to Phase 3 in Cushing’s syndrome based on its extremely promising Phase 2 efficacy and safety data. We expect our GRACE trial to serve as the basis for relacorilant’s NDA in Cushing’s syndrome, which we plan to submit in the second half of 2023," said Dr. Guyer. "The Phase 3 GRADIENT trial will produce valuable data about an etiology of Cushing’s syndrome that has not been subject to rigorous, controlled study, but affects many patients."

Conference Call

We will hold a conference call on November 3, 2022, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). Participants must register in advance of the conference call by clicking here. Upon registering, each participant will receive a dial-in number, and a unique access PIN. Each access PIN will accommodate one caller. Additionally, a listen-only webcast will be available by clicking here. A replay of the call will be available on the Investors / Events tab of www.corcept.com.

Hypercortisolism

Hypercortisolism, often referred to as Cushing’s syndrome, is caused by excessive activity of the hormone cortisol. Endogenous Cushing’s syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing’s syndrome, with about 3,000 new patients diagnosed each year. Symptoms vary, but most patients experience one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper-body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Hypercortisolism can affect every organ system and can be lethal if not treated effectively. Corcept holds patents directed to the composition of relacorilant and the use of cortisol modulators, including Korlym, in the treatment of patients with hypercortisolism.